Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Miriam Hospital
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00142935
First received: September 1, 2005
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse treatment. The purpose of this study is to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study will evaluate the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.


Condition Intervention
HIV Prevention
Opioid-Related Disorders
Behavioral: Pre-release Initiation of MMT
Behavioral: Post Release Initiation of MMT.
Behavioral: Standard of Care Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Opiate Replacement Therapy at Release From Incarceration

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Treatment engagement [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]
  • Time to Treatment engagement from prison release [ Time Frame: 1.5, 6 month follow-up interivews ] [ Designated as safety issue: No ]
  • HIV risk behaviors [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug use [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: No ]
  • Fatal overdose [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: Yes ]
  • Non-fatal overdose [ Time Frame: 1.5, 6, 12, 18, 24 month follow-up interviews ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: October 2005
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
Behavioral: Pre-release Initiation of MMT
Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
Experimental: 2
Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
Behavioral: Post Release Initiation of MMT.
Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
Active Comparator: 3
Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
Behavioral: Standard of Care Plus
Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.

Detailed Description:

A substantial proportion of individuals addicted to heroin are incarcerated while addicted and a majority of individuals released from a correctional setting have a history of heroin addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV transmission and other problems, including drug relapse and overdose. Methadone treatment is the most widely used opiate replacement therapy in the United States and has been shown to decrease HIV risk, as well as drug use, addiction relapse, and criminal activity. The purpose of this study is to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study will evaluate the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.

Participants in this 3-year study will be randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. Participants enrolled in Group 3 will be referred to a program of choice upon release from incarceration without receiving financial assistance. All participants will have the opportunity to partake in existing support programs available at the Rhode Island Department of Corrections while incarcerated and in the community upon release. Follow-up assessments will occur at Months 1.5, 6, 12 and 24. These will include interviews and urine specimens for toxicology analysis to verify self-reports.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently incarcerated at the Rhode Island Department of Corrections with a scheduled release date at least 28 days after enrollment
  • Incarceration length not to have exceeded two years at the time of enrollment
  • Heroin dependent with self-reported heroin injection in the month prior to incarceration OR enrollment in a methadone treatment program prior to incarceration for heroin addiction with a history of injection drug use
  • Desire to enter methadone treatment upon release and plans to secure funding for methadone treatment after study completion
  • History of prior tolerance to methadone
  • History of at least one drug-related incarceration
  • Speaks English or Spanish
  • Plans to remain in Rhode Island for the duration of the study (24 months)
  • Ability to provide at least two names of individuals who can verify participant information

Exclusion Criteria:

  • Currently receiving methadone at the Rhode Island Department of Corrections
  • Currently undergoing a non-narcotic detoxification from illicit opiates at the Rhode Island Department of Corrections
  • Plans to leave Rhode Island within the two years following enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142935

Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Josiah D Rich, M.P.H., M.D. The Miriam Hospital
  More Information

No publications provided

Responsible Party: Josiah D. Rich, MD, MPH, Principal Investigator, The Miriam Hospital/Warren Alpert Medical School of Brown University
ClinicalTrials.gov Identifier: NCT00142935     History of Changes
Other Study ID Numbers: NIDA-18641-1, R01-DA018641-1, DPMC
Study First Received: September 1, 2005
Last Updated: May 4, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014